Avoiding Risk Analysis Pitfalls: Implementing Linked DFMEA, HARA, and FTA

by Gregory Gruska,Nikhil Unnikrishnan published on December 20, 2024

Disconnected risk analysis methods can lead to gaps in safety and efficiency. In this webinar, we explore how integrating Failure Mode and Effects Analysis (FMEA), Hazard Analysis and Risk Assessment (HARA), and Fault Tree Analysis (FTA) can significantly improve risk identification, management, and functional safety assurance.

Highlights include:

Overview of FMEA (AIAG-VDA and AIAG 4th), HARA, and FTA methodologies
Common challenges with disconnected risk assessments
Benefits of digitalizing and linking FMEAs with HARAs and FTAs
Demonstration of how Omnex software supports integrated risk analysis
Using FTAs to trace simultaneous failure causes and align with Functional Safety goals

Whether you're managing product design, safety, or compliance, this session will help you streamline your risk management process and build a more resilient safety strategy.

Speaker

Nikhil Unnikrishnan

Nikhil Unnikrishnan is a Consultant with a broad range of experience, involved in the design & development of hardware, software and mechanical systems and components. He has worked with organizations to analyze process deficiencies and drive improvement by implementing best-in-class practices conforming to internationally recognized standards such as Automotive SPICE®, ISO 26262 Functional Safety, ISO 9001 & IATF 16949 Quality Management Systems. Nikhil has been involved with performing detailed documentation reviews, Automotive SPICE®, Functional Safety & QMS assessments, process documentation development and conducting roll-outs for numerous leading automotive organizations including multiple Software and Hardware systems. Mr. Unnikrishnan is a Certified Green Belt in Lean Six Sigma Methodologies (CLSSGB) and also Certified Quality Process Analyst (CQPA). He is an Exemplar Global certified Lead Auditor for IATF 16949:2016 and ISO 9001:2015.

Gregory Gruska

Greg Gruska - Omnex Champion for ISO 26262, and a Fellow of the American Society for Quality (ASQ) • Omnex Inc. Greg Gruska, Omnex Champion for Functional Safety and ASQ Fellow, specializes in ISO 26262 engagement, systems engineering, and reliability/safety analysis. With experience spanning various industries worldwide, including automotive, he excels in integrating Functional Safety into development processes. Formerly of General Motors, he managed Quality Engineering, focusing on statstics and new technology development. Greg’s expertise extends to Functional Safety, SOTIF, and hardware metrics, offering guidance to OEM teams. A prolific writer and speaker, he has published numerous works on quality management, statistical analysis, and risk control. Greg, a licensed Professional Engineer and ASQ certified Quality Engineer, is highly regarded as a risk management authority and active member of industry committees. He provides consulting, training, and software services in Ann Arbor, MI, with a specialization in Automotive Software and ISO compliance.